Infertility is a “woman’s thing,” right? Not so fast. It’s estimated that in a third of infertility cases, at least part of the issue is on the man’s side.
So, just as there are fertility calendars, apps and tests for women to use to increase their chances of getting pregnant, a startup called Sandstone Diagnostics is developing a tool it hopes will empower men to take control of their fertility, too.
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The company’s Trak Fertility system includes an engine, a disposable test plate and seal, a sample collection cup and a dropper. A semen sample is collected in the cup, swirled around, put in the test plate with the dropper and sealed. Then it’s loaded into the centrifuge, which spins the sample for several minutes. Sperm cells collect at the end of the test plate, which is calibrated like a thermometer to deliver a sperm cell count reading. The device also tests the motility of the sperm, said Sara Naab, one of the company’s three staffers.
The idea, she said, is that men would use the test not so much as a diagnostic tool to determine whether they have fertility problems but as a tracking tool to guide whether they need to see a fertility expert of make changes to their lifestyle. A number of factors are thought to contribute to low sperm counts or low motility, from hormone imbalances to injuries to lifestyle factors like alcohol, tobacco and drug use, stress, weight and medications.
“Like women, men have kind of a sliding scale of fertility, but the problem is that men don’t have any feedback about their reproductive health,” explained Sara Naab, the third member of the Sandstone team. “Women have a cycle. If we miss a month, we recognize that something is going on. Men don’t have that same feedback.”
Eventually, Trak Fertility will come with a web portal or app to track test results over time, but Naab said she wasn’t sure whether that would be developed in-house or through a partnership with an existing product.
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For now, Naab and co-founders Greg Sommer and Ulrich Schaff are focused on getting the device and disposables manufactured and perfected. They’ve been working with a handful of fertility clinics in the Bay Area testing the accuracy and repeatability of the system with good results, she said. After another round of preclinical trials early next year, they’ll launch a user study and eventually submit for 510(k) clearance by the end of the summer. They’ve raised what Naab called a “fairly modest seed round” to and will soon begin raising a Series A.
Meanwhile, they’re also pushing an education initiative. Through a website craftily named dontcookyourballs.com, they’re hoping to inspire men to learn about male infertility and what to do when they have it by presenting science-based information in a light-hearted fashion.
That education and research component is also part of the company’s long-term plans, Naab said. Because not much solid evidence exists about what helps and hurts male fertility and why and when it does so, a big data research and analysis component is part of the plan. She also said the company would like to continue building on to the device to make a complete solution for fertility clinics and homes that can do more detailed sperm analysis as well as hormone testing.
The device was developed while Sommer and Schaff were research scientists at Sandia National Laboratories. They were working on point-of-care blood tests to detect radiation exposure and biotoxins and found that they had built something portable that was great at dealing with complex samples, cell counts and assays and could have many other applications. They licensed the technology and formed the company last year.
Naab envisions a few key target markets for the device, including couples who are family planning, have been struggling to conceive, or who don’t want to go to a fertility clinic either because it’s expensive or they’re just private people. There are a few options for at-home testing, like SpermCheck fertility test, but most of those are designed to give men an indication whether their sperm count is “normal,” rather than what the count actually is, Naab said.